The answers included in this document are based on Guidance Document N°1 for the Development of OECD Guidelines for the Testing of Chemicals , and on current practice. Procedures described can be changed provisionally or permanently with agreement of all countries. The time needed to develop and approve a new or revised Test Guideline largely depends on countries reaching agreement.
OECD Test Guidelines are harmonised test methods included in the OECD Council Decision on Mutual Acceptance of Data. This means that “data generated in the testing of chemicals in an OECD Member country (or some non-member economies ) in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other member countries (or non member economies) for purposes of assessment and other uses relating to the protection of man and the environment”.
Test Guidelines, including any annex or appendix, are submitted to Council for adoption before their publication. All other documents produced by the Test Guidelines Programme (TGP) are published in the Series on Testing and Assessment after their declassification by the Joint Meeting.
National Coordinators nominated by governments of member countries, and by some non-member economies and the European Commission have a central position in the TGP. The Working Group of the National Coordinators of the Test Guidelines Programme (WNT) meets once a year and oversees the work of the TGP. The WNT reports to the Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology (Joint Meeting), which is the policy body overseeing the OECD Chemicals Programme.
Stakeholders from industry through the Business and Industry Advisory Committee, from animal welfare organisations through the International Council for Animal Protection in OECD Programmes, and as appropriate, from trade unions through the Trade Union Advisory Committee, and from environmental NGOs through the European Environmental Bureau, provide input but do not make final decisions.
1. Project submission for inclusion in the TGP work plan [in-page link]
Submission of a project proposal by a National Coordinator, the European Commission or the Secretariat, for inclusion in
the TGP work plan.
2. Validation and validation peer review [in-page link]
Any test method should be validated before becoming an OECD Test Guideline (Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment).
on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment).
The validation is peer reviewed via a process agreed by the WNT.
3. Experts discussions and WNT agreement on the draft Test Guideline [in-page link]
4. Adoption process from WNT approval to Council adoption [in-page link]
SPSFs must be submitted for projects for a new or revised Test Guideline, or for other Test Guideline-related documents (e.g. guidance document, detailed review paper, and background document). SPSFs are assessed by WNT members who can:
Governments via their National Coordinators, the European Commission, the Secretariat and any OECD programme (e.g. The Task Force on Biocides) can submit SPSFs. Other stakeholders can be associated with the projects submitter.
The SPSF should inform on the work plan for the project. In order to ensure the resources necessary to the development of a draft Test Guideline through its finalisation, the SPSF should also inform on resources that will be provided by the lead country for the validation and development of the draft Test Guideline. Information on related regulatory needs and validation status, applicability and limitation of the methods is requested.
A formal proposal can be submitted at any time. But, proposals submitted less than 2 months before the next WNT will not be assessed during that meeting.
The SPSFs are assessed by the National Coordinators, the European Commission and other stakeholders such as BIAC and ICAPO. But, the decision to include a project in the work plan is made by the National Coordinators and the European Commission only.
When the WNT assesses a SPSF, it is requested to respond to the following question: “Taking into account the project information, requested above, does this project meet the needs of the member countries for addition to the work plan of the Test Guidelines Programme?”
A project for an OECD Test Guideline is expected to be included in the work plan if at least two countries from different regions (North America, Europe and Asia-Pacific) consider that the Test Guideline is useful.
It is possible to submit an informal preliminary proposal to gauge views of other countries on the project, before its formal submission. The WNT is informed that a new preliminary proposal is posted on the protected website. Any comments should be sent directly to the lead country. Preliminary proposals can be submitted by any stakeholder, e.g. industry, with a view to finding a lead country to take over the responsibility for the project.
SPSFs for projects for Test Guidelines can be submitted at different stages of validation of the test method:
(i) ongoing pre-validation
(ii) ongoing validation, or
(iii) completed validation.
The duration of the project is highly dependent on the validation status, which has to be clearly described in the SPSF.
If a SPSF for a project for Test Guideline is submitted after the method has been fully validated, the validation report and, if available, the validation peer review report, should be submitted to the Secretariat together with the draft Test Guideline. These documents will then be made available to the WNT.
If a work plan project is under validation by a country, the WNT should be regularly informed of its progress, and any issues related to this validation should be reported. It is recommended that SPSFs should be submitted after the pre-validation stage, when it can be expected that the validation outcome of the method will allow the development of a Test Guideline.
Who is responsible for the validation of test methods before development of OECD Test Guidelines?
OECD involvement in the validation of test methods is variable, as shown below by examples:
Example of test method validation for endocrine disruption mechanism
For methods to detect endocrine disruption, the validation is managed by a validation management group (VMG) on mammalian toxicity testing or a VMG on ecotoxicity testing, as appropriate. These two OECD experts groups, which report to the WNT, decide how laboratories in countries should conduct validation (e.g. number and identification of chemicals to be tested, reference chemicals, number of replicates, statistical interpretation of results, and criteria for positive or negative test results). An Advisory Group on Endocrine Disrupters Testing and Assessment is requested to comment on the validation reports. The WNT is then requested to approve the submission of the report to the Joint Meeting for declassification and publication in the Series on Testing and Assessment.
Given the high number of in vitro methods under development in the last years, methods are being validated by countries. Experts from these countries report on progress with the validation at the meetings of the VMG for non-animal testing. The VMG comments and provides advice on the validation rather than manages the validation of the test methods.
Example of test method validation for ecotoxic effects
For simple methods for ecotoxicity testing (e.g., tests on invertebrates), one lead country (or a small group of lead countries) is responsible for the method validation and for providing a validation report. For more complex test methods, (e.g. test on birds or on fish embryo), specific expert groups manage the (retrospective) validation and decide how laboratories in countries should conduct experimental validation, if such an experimental validation is considered necessary by countries.
Example of test method validation for human health effects
Specific expert groups are established, in most cases, to manage retrospective validation of in vivo methods for toxicity testing (e.g. alternative method for acute inhalation toxicity). The first draft of a retrospective validation is usually developed by experts of the lead country or by a consultant.
For in vitro methods for toxicity testing, it is expected that most validation and peer review reports will be developed jointly by validation/peer review bodies (ECVAM/ICCVAM/JaCVAM) and submitted jointly by the European Commission, the United States and Japan; this should make the validation process more efficient, and prevent requests for additional experimental work or statistical analysis.
Duration of the validation work, after a SPSF has been submitted and a project accepted, depends on the complexity of the endpoint(s) to be tested and on the validation status of the test method at the time the project is submitted. If the method is still at the pre-validation stage, it may take more than 2 years to complete the validation process. For some test methods for endocrine disruption, two to three validation phases were necessary in the past to fulfill all validation criteria, sometimes taking several years. When appropriate data are already available, it is possible to conduct a retrospective validation, and one year may be sufficient for the validation.
The OECD Secretariat has recently organised a few independent peer reviews for endocrine disrupters screening methods, with consultants as peer review managers. International peer reviewers were proposed by National Coordinators and confirmed by the peer review managers. Peer review packages are posted on the public website for TGP. International independent peer reviews can also be organised by individual countries. Circulation of the validation reports to the WNT and peer reviews by national experts in countries or by OECD expert groups are considered appropriate for the validation of simple test methods.
Validation peer review reports are posted on the public website, accompanied by WNT agreement on the follow-up of the peer review report. The WNT may agree on recommendations from the peer review, e.g. to further work to complete validation, or to develop criteria or considerations, such as limitations of the test methods, which should be included in the draft Test Guideline.
The first version of a Test Guideline is usually developed by the lead country and sent to the WNT for comments. In most cases, an expert group is established after the first commenting round to address comments received from the WNT. These comments include compilations of comments from national experts and national positions prepared by National Coordinators, as well as comments from other stakeholders. The expert group meets once or several times, as appropriate. There is at least one commenting round. Usually, 2 to 3 commenting rounds are necessary before the submission of a draft Test Guideline to the WNT for approval. Comments are either technical comments (e.g. related to the validation or to performance criteria) or policy comments (e.g. related to animal welfare concerns).
The Secretariat, in cooperation with the lead country or an expert group, responds to comments and revises the draft Test Guideline. Responses to technical comments are expected to be provided by the lead country or the expert group.
This mostly depends on the number and nature of comments received from governments at each commenting round. It also depends on time taken by the lead country to respond to technical comments. For the first commenting round, National Coordinators usually have 2 months to collect comments from national experts and prepare a national position. For subsequent commenting round, National Coordinators usually have six weeks to respond. The time taken by lead countries to respond to technical comments varies widely with countries.
Yes, each time a new draft is developed and available for WNT comments, it replaces the previous draft on the public website.
Draft Test Guidelines are used in some cases by industry or governments. On the public website, a warning introduces the draft Test Guidelines: “Draft Test Guidelines are not part of Mutual Acceptance of Data. Please consult with National Authorities before using draft Test Guidelines.”
The four main steps of the adoption process are:
It takes now approximately 3-5 months to publish Test Guidelines that have been approved by the WNT. It should be noted that it is possible to use the written procedure for WNT approval (Guidance Document for the Development of OECD Guidelines for the Testing of Chemicals, Par. 22). Usually, after WNT approval, comments by higher bodies are only of an editorial nature, if any.